Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626350
Recruitment Status : Enrolling by invitation
First Posted : August 13, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia.

The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.

A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.


Condition or disease
Gastrointestinal Neoplasia Hirschsprung's Disease Esophageal Obstruction Gastroparesis Spastic Esophageal Disorders Zenker's Diverticulum

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : June 12, 2023
Estimated Study Completion Date : June 12, 2025





Primary Outcome Measures :
  1. Technical and clinical success in performing submucosal endoscopy [ Time Frame: baseline to one year ]
    Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.

  2. Adverse Events [ Time Frame: baseline to one year ]
    as defined by published ASGE criteria


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: During procedure ]
    Procedure time

  2. Submucosal endoscopy technique and device used [ Time Frame: During procedure ]
    Submucosal endoscopy technique and device used



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
A prospective database/registry of patients undergoing submucosal endoscopic procedures will be formed. Women and minorities will be included as they are frequently found to have indications for which submucosal endoscopic procedures may be indicated.
Criteria

Inclusion Criteria:

  1. Patients who will undergo submucosal endoscopy
  2. Age >18 years

Exclusion Criteria:

  1. Age <18 years
  2. Pregnancy
  3. Coagulopathy (platelets less than 50, INR more than 1.8)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626350


Locations
Layout table for location information
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver

Additional Information:

Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03626350    
Other Study ID Numbers: 18-0046
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diverticulum
Gastroparesis
Hirschsprung Disease
Esophageal Diseases
Zenker Diverticulum
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Digestive System Abnormalities
Megacolon
Colonic Diseases
Intestinal Diseases
Congenital Abnormalities
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Pathological Conditions, Anatomical
Diverticulum, Esophageal